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Regulatory Compliance

  • Internal GMP Audits

  • SOP Preparation

  • Analytical Laboratories Audit

  • Prepare responses to 483s

  • Risk Assessment of Supplies

  • Site and Product Registration

  • Correct Adverse Findings

  • Drug Master File Preparation

  • Mock Pre-Approval Inspections

  • Evaluation of Quality Systems

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DNA

GMP Consultant, Drug Master File, Engineering Services, DMF, SOP, Protocols, FDA Documentation, Seperation Technology, Solvent Recovery System, Drying System, Mixing Technology and Fluid Dynamics, Process Operation and Yeild Optimisation, Heat Transfer Technology.